IngentaConnect A prospective study of adverse drug reactions as a cause of admis...

Authors: MARTÍNEZ-MIR, I.¹; GARCÍA-LÓPEZ, M.²; PALOP, V.³; FERRER, J. M.³; ESTAÑ, L.³; RUBIO, E.³; MORALES-OLIVAS, F. J.³

Source: British Journal of Clinical Pharmacology, Volume 42, Number 3, September 1996 , pp. 319-324(6)

Publisher: Blackwell Publishing

Abstract:

1A total of 512 consecutive paediatric hospital admissions of children 2 years old or less were evaluated to assess the extent and pattern of admission caused by suspected adverse drug reactions (ADRs). The proportion of suspected ADRs related to hospital admissions was 4.3%.

2The organ-systems most commonly implicated were the central nervous system (40.5%), digestive system (16.7%), and skin and appendages (14.3%). Together, they accounted for 71.5% of admissions attributed to ADRs. The most common clinical manifestations inducing admission were convulsions (4 cases), dizziness (4), vomiting (3), and tremor, fever, itching and apnoea (2 cases each).

3The four classes of drugs most frequently suspected in admissions due to ADRs were respiratory drugs (35%), anti-infective agents (25%), drugs active on the central nervous system (15%) and drugs used in dermatology (10%). The most common drugs related to ADRs were a combination of chlorpheniramine, diphenhydramine, phenylephrine, guaiphenesin and salicylic acid (4 cases), followed by fenoterol, adrenaline, paracetamol, DTP vaccine and antipolio vaccine (2 cases each).

4There were no significant differences between children older and younger than 1 year (odds ratio 0.89; 95% CI 0.37-2.17) or between the sexes as regards hospital admittance due to suspected ADRs (odds ratio 1.94; 95% CI 0.72-5.42).

5The results of this kind of study may be influenced by patterns of drug utilization. Nevertheless, the lack of specific studies of drug effects in young children makes it desirable to carry out pharmacoepidemiological studies in this age group.

Keywords: adverse drug reactions; hospital admission; paediatric patients

Document Type: Research article

DOI: 10.1046/j.1365-2125.1996.04076.x

Affiliations: 1: Servei de Investigació, Hospital General Universitari, Diputació de València, València, 2: Hospital Infantil La Fe, Servei Valencià de Salut, València, 3: Departament de Farmacologia, Universitat de València, València, Spain

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A prospective study of adverse drug reactions as a cause of admission to a paediatric hospital